TY - JOUR
T1 - A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail
AU - Gordon, Michael S.
AU - Mitchell, Shannon Gwin
AU - Blue, Thomas R.
AU - Vocci, Frank J.
AU - Fishman, Marc J.
AU - Murphy, Sean M.
AU - Couvillion, Kathy
AU - Maher, Kelly
AU - Ryan, Danielle
AU - Wenzel, Kevin
AU - Danner, Martha L.
AU - Jarvis, Daniel K.
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2021/9
Y1 - 2021/9
N2 - This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
AB - This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
KW - Extended-release buprenorphine
KW - Extended-release naltrexone
KW - Jail
KW - Justice-involved
KW - Medications for opioid use disorders
UR - http://www.scopus.com/inward/record.url?scp=85097885505&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85097885505&partnerID=8YFLogxK
U2 - 10.1016/j.jsat.2020.108241
DO - 10.1016/j.jsat.2020.108241
M3 - Article
C2 - 33339633
AN - SCOPUS:85097885505
SN - 0740-5472
VL - 128
JO - Journal of Substance Abuse Treatment
JF - Journal of Substance Abuse Treatment
M1 - 108241
ER -